Nexium/Nexium IV

Nexium/Nexium IV

esomeprazole

Manufacturer:

AstraZeneca

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Esomeprazole
Indications/Uses
Prevention of gastric & duodenal ulcers associated w/ NSAID therapy in patients at risk. Tab: Erosive reflux esophagitis; long-term management of patients w/ healed esophagitis to prevent relapse; symptomatic treatment of GERD. In combination w/ an appropriate antibacterial therapeutic regimen for the eradication of H. pylori & healing of H. pylori associated duodenal ulcer & prevention of relapse of peptic ulcer in patients w/ H. pylori-associated ulcers. Healing of gastric ulcers associated w/ NSAID therapy. Prevention of gastric &/or duodenal ulcers associated w/ low dose aspirin therapy. Zollinger Ellison syndrome. Inj: Alternative to oral therapy when oral intake is not appropriate for GERD in patients w/ esophagitis &/or severe symptoms of reflux; healing of gastric ulcers associated w/ NSAID therapy; prevention of rebleeding following therapeutic endoscopy for acute bleeding gastric or duodenal ulcers.
Dosage/Direction for Use
Tab Adult & adolescent from 12 yr Erosive reflux esophagitis 40 mg once daily for 4 wk. Long-term management of patient w/ healed esophagitis to prevent relapse 20 mg once daily. Symptomatic treatment of GERD 20 mg once daily in patients w/o esophagitis. Subsequently, 20 mg once daily when needed. Adult Healing of H. pylori-associated duodenal ulcer & prevention of relapse of peptic ulcer in patient w/ H. pylori-associated ulcer 20 mg w/ amoxicillin 1 g & clarithromycin 500 mg, all bd for 7 days. Healing of gastric ulcer associated w/ NSAID therapy 20 mg once daily for 4-8 wk. Prevention of gastric & duodenal ulcer associated w/ NSAID therapy in patient at risk 20 mg once daily. Prevention of gastric &/or duodenal ulcer associated w/ low dose aspirin therapy in patient at risk 20-40 mg once daily. Prevention of rebleeding of gastric or duodenal ulcer 40 mg once daily for 4 wk after IV-induced prevention of rebleeding of peptic ulcers. Zollinger-Ellison syndrome 40 mg bd. Max: 80-160 mg. Doses >80 mg daily should be divided & given bd. Patient w/ severe liver impairment Max: 20 mg. Inj Reflux oesophagitis 40 mg once daily. Symptomatic treatment of reflux disease 20 mg once daily. Healing of gastric ulcer associated w/ NSAID therapy 20 mg once daily. Prevention of gastric & duodenal ulcer associated w/ NSAID therapy 20 mg once daily. Prevention of rebleeding of gastric & duodenal ulcer 80 mg as bolus infusion over 30 min, followed by continuous IV infusion of 8 mg/hr for 3 days. 20 or 40 mg IV over a period of at least 3 min. Infusion: 20 or 40 mg IV infusion over a period of 10-30 min. 80 mg bolus dose given as continuous IV infusion over 30 min. 8 mg/hr dose given as continuous IV over 71.5 hr. Patient w/ severe renal insufficiency GERD Max: 20 mg daily. Bleeding ulcer Initial bolus dose of 80 mg for infusion, continuous IV infusion dose of 4 mg/hr for 71.5 hr may be sufficient.
Administration
May be taken with or without food: For patients w/ swallowing difficulties, the tab may also be dispersed in ½ glass of non-carbonated water. No other liqd should be used. Stir gently until the tab dissolves into little pellets & drink the liqd w/ the pellets immediately or w/in 30 min. Rinse the glass w/ ½ glass of water & drink. Do not chew/crush the tab or the pellets. The dispersion may also be administered via a nasogastric tube.
Contraindications
Hypersensitivity to esomeprazole or other substituted benzimidazoles.
Special Precautions
Exclude malignancy in the presence of significant unintentional wt loss, recurrent vomiting, dysphagia, haematemesis or melaena; & when gastric ulcer is suspected or present. Monitor patients at risk for developing osteoporosis or osteoporotic fractures. Increased risk of Clostridium difficile-associated diarrhoea. Symptomatic & asymptomatic hypomagnesaemia. Monitor Mg level for patients expected to be on prolonged treatment of PPI or who are taking medications that may cause hypomagnesaemia eg, digoxin & diuretics. Discontinue treatment if signs or symptoms consistent w/ cutaneous lupus erythematosus & systemic lupus erythematosus occur. Concomitant administration w/ atazanavir & nelfinavir is not recommended. Concomitant use w/ clopidogrel; methotrexate. Pregnancy. Do not use during lactation. Do not use in childn <12 yr. Tab: Long-term treatment for >1 yr. Fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency.
Adverse Reactions
Headache; abdominal pain, constipation, diarrhoea, flatulence, nausea/vomiting. Inj: Administration site reactions.
Drug Interactions
Decreased absorption of ketoconazole, itraconazole & erlotinib. Increased bioavailability of digoxin. Increased plasma conc of drugs metabolised by CYP2C19 eg, diazepam, citalopram, imipramine, clomipramine, phenytoin. Elevated INR w/ warfarin or other coumarine derivatives. Decreased max inhibition of platelet aggregation of clopidogrel. Increased Cmax & AUC of cilostazol. Increased AUC & prolonged elimination t½ of cisapride. Increased serum levels of tacrolimus & other antiretroviral drugs eg, saquinavir. May elevate & prolong serum levels of methotrexate &/or its metabolite hydroxymethotrexate in high doses. Decreased serum levels of antiretroviral drugs eg, atazanavir & nelfinavir. May double the exposure w/ clarithromycin & voriconazole. Decreased serum levels w/ CYP2C19 or CYP3A4 (eg, rifampicin & St. John's wort).
ATC Classification
A02BC05 - esomeprazole ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).
Presentation/Packing
Form
Nexium IV powd for inj 40 mg
Packing/Price
1's
Form
Nexium gastro-resistant tab 40 mg
Packing/Price
14's
Form
Nexium gastro-resistant tab 20 mg
Packing/Price
14's
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